· Subject matter expert on development team of drug safety software for the rapid, real time on-line collection of serious adverse event data from health care professionals and the public.Patent for this software now being applied for.Also developed regulatory department, headed response team for a governmental inspection (UK), corporate trainer for GCP, pharmacovigilance and inspection preparation.Developed regulatory document database/repository in the document management system.

· Responsible for all clinical trials done by Medical Department from protocol concept to final clinical study report.Supervises 8 nurses and CRAs.Included trials on devices, drugs and biologics.Consultant to Advanced Drug Delivery Group on their drug/device combination products.Brought in external consulting group (Metasolutions Inc.) to audit the clinical research functions.

3.European Safety Group: based in the UK which includes the SP Qualified Person for the EMEA as well being responsible for reporting “centrally approved” and “mutually recognized” drugs’ AEs.

· Re-engineered department in 1994-5 with CSC Index Inc.Developed new PC based client-server computer system for AE processing (called “CAVIAR” -Computerized Adverse Event Information, Analysis and Reporting System) and reporting using an outside programming company. Version 1.0 launched May 6, 1995 with periodic updates through 2003.Licensed CAVIAR to the software company that developed it on a royalty basis for sale to other companies.

· Consultant to Legal Department and involved in depositions and litigation in safety matters.Represented company in various governmental safety meetings for SP investigational and marketed products (US FDA and health authorities in Australia, France, WHO, Italy, Canada, Finland, Pharmacovigilance Working Party of the EMEA etc.).

· Head of the MedDRA Transition Task Force (1998 – 2002). Head Complaint Handling Reengineering Task Force (2000-2001).Member ICH Expert Working Group on E2B(M); co-chairman ofExpert Working Group onV1 (PSUR revisions). Responsible for the writing of the corporate policy on AE handling as well as review of all business units’ local SOPs on AE handling.

· Head of a clinical research team of ~15 medical professionals and support staff.Products handled:

· HOE 077 (Prolyl Hydroxylase Inhibitor).Responsible for development and implementation of the US clinical program for the development of this drug for liver cirrhosis.

· Trental (Pentoxiphylline). Responsible for design and implementation of phase IV trials and new indications (particularly for use in diabetic and arterial leg ulcers) in the U.S. and Canada.Rewrote investigator brochure.Wrote and directed the clinical hemorheology study required by FDA for NDA approval.Organized investigator meeting. Prepared clinical-statistical reports on studies completed.Assisted in preparation of publications.In charge of development and implementation of the clinical program for the use of Trental to treat and prevent cyclosporin/amphotericin B induced nephrotoxicity.

· HOE 760 (Roxatidine Acetate - H2 Blocker). Responsible for design, implementation and completion (on time and on budget) of the US and Canadian clinical development program (late phase I, II and III) for Roxatidine HOE 760.Wrote protocols, implemented and completed 4 major multi-center pivotal trials. Organized consultant and investigator meetings.Helped implement GCP (US style) in Eastern and Western Europe.Prepared and periodically revised investigator brochure.Wrote clinical-statistical reports.Primary participant in presentation of data to FDA's GI division.Chairman of overall project development committee and member of Frankfurt-based International Project Group.Liaison with phase IV group and marketing group.Member of Gastroenterology Worldwide Marketing Group (Frankfurt).Responsible for the preparation of the clinical portion of the NDA and chairman of the NDA preparation committee.Prepare responses to clinical questions from FDA on NDA.Wrote and prepared manuscripts of clinical trials and review articles for journal publication.Grant budget $2 million per year.

· HOE 843 (Aldose Reductase Inhibitor). Responsible for design and implementation of the US clinical program (late phase I, II and III) for development of this compound HOE 843.Organized methodology and new technology workshop and investigator meeting.Devised strategy to overcome FDA moratorium on new studies.Chairman of project development coordination committee and member of Frankfurt-based International Project Committee. Liaison to licensor of this product.Participant in meeting with FDA's endocrine division.Assisted in interim analysis of the major US clinical trial.Grant budget $2 million per year.

· HR 810 (Cefpirome - antibiotic). Responsible for clinical trials being done through third parties (contract research organizations) in the United States, Argentina and Mexico for pneumonia and skin and soft tissue infections.Chose third parties, negociated and wrote contracts and monitor the trials along with third parties.

· Developed and implemented phase IV programs and new indications for Uniphyll (theophylline) and Fibermed Biscuit (OTC).Prepared data for response to FDA on lack of bioavailability of preparation.Developedphase II and III program for MS-Contin in acute cancer pain.Train sales representatives in GI.Reviewed advertising on marketed GI products.

· Developed and implemented phase IV programs and new indications for iv and oral Isordil (isosorbide dinitrate) and Surmontil (tri-cyclic antidepressant). Review advertising on these agents.Responded to questions from physicians on marketed products.Prepared investigator brochures and scientific literature on marketed products for physicians, state formularies and conferences.Represented company at national medical conferences and at FDA meetings (Cardiorenal Division).